KR20040093450A - Transseptal facilitation using sheath with electrode arrangement - Google Patents

Abstract

A method of performing surgery on a fossa ovalis in the septum wall of the heart includes providing an envelope having a body having a lumen through the body and an open end at the distal end of the body. The body also has at least one electrode at its distal end. Ovals of the septum wall are identified by using at least one electrode of the envelope.

Description

Transseptal facilitation using sheath with electrode arrangement

The present invention relates to methods and apparatus for facilitating diagnostic and therapeutic surgery in tissues, and more particularly to methods and apparatus for performing transseptal facilitation procedures.

There are many medical and surgical procedures involving a patient's heart 100 that require transcatheter left heart catheterization, that is, catheterization through the left atrium 110 as shown in FIG. 1. The transseptal approach involves intervening cardiologists who perform advanced mitral balloon valve repair, and cardiac electrolysis that removes the left adrenal canal or implements catheter atrial-fibrillation therapeutic tactics. It is an essential manipulation that gives access to all cardic eletrophysiologists.

In 15-25% of the normal healthy population, the intraarterial septum (IAS) 105 has an oval or elliptical hole 107, i.e., an open elliptical hole (PFO). The PFO is one of three obligatory shunts in normal fetal intrauterine blood circulation. Accidental appearance of the PFO often allows for rapid passage of the guidewire past the septum 105 across the right atrium 115. Pediatric cardiologists often use this route.

For surgery on a patient who already has a PFO (hole already present in the ovary 107), a transesophageal ultrasound probe (not shown) is generally inserted into the patient's mouth and placed in the esophagus. In most cases, the transesophageal ultrasound probe is placed approximately 30 to 35 cm from the mouth, ie most of the time, just above the patient.

Under transesophageal echocardiography (TEE), i.e., transesophageal ultrasound guidance, a wire (not shown) is inserted into the right atrium 115 through an appropriate vessel, such as an inferior vena cava 108, wherein the wire is in contact with the ovary. Guided through oval 107 by slowly lifting a tissue flap away from the pattern opening of the IAS at 107. Once the wire is inserted through the oval 107, the wire is guided to one lung vein 116 for positioning the wire distal end to properly place and secure the wire in the opening of the lung vein 116. Thus, the lung vein 116 proved to be a very reliable and stable anchor point for the wire.

Once the wire is properly positioned within the oval 107 and secured to the lung vein 116, the catheter sheath (“over-the-wire” manner) is guided through the wire through the right atrium 115 and the oval 107 to provide an example. For example, it is placed in the left atrium 110 in close proximity to the opening of the lung vein 116.

Once the catheter sheath is properly positioned, the wire is removed from the patient heart 100 and other treatment and / or diagnostic devices are delivered through the catheter sheath. Such devices include implantable devices such as implanted pacemakers, electrodes, atrial septal defect (ASD) closure devices, and the like. Thus, the implantable device may be delivered by a conventional delivery device such as an Amplatzer® delivery system manufactured by AGA Medical Corporation of Golden Valley, Minnesota, USA.

After the catheter sheath is placed, the implantable device is deployed within the oval 107 from the catheter sheath. In the deployed state, the implantable device is implanted into the IAS 105 to close the opening (PFO) of the oocyte 107.

All patients need a transseptal puncture technique (preceding approach). However, this process can lead to various life-threatening complications, some of which can be caused by insufficient anatomical landmarks in the heart 100. Therefore, several methods have been proposed for guiding transesophageal catheterization, including transesophageal echocardiography (TEE) and intracardiac echocardiography (intracardiac echo: ICE).

When taking the preceding approach by TEE, the transesophageal ultrasound probe is placed in the patient's esophagus as described above. While guided by transesophageal ultrasound imaging, an opening is made in the IAS 105 in the oval 107 for convenient use and accommodation of other treatments and / or diagnostic devices. Thus, the opening is a penetrating device having a penetrating member such as a standard needle catheter, for example St. Paul, Minn. Made by the BRK ^TM series transseptal needle produced by Jude Medical Inc. Accordingly, under transesophageal ultrasound guidance, the needle catheter is initially placed in the right atrium 115 and placed in the oval 107. In this advantage, the tip of the needle of the needle catheter penetrates the oval 107, and the catheter is inserted into the left atrium 110 through the oval 107 via a new opening in the oval 107 by the needle catheter. Once an opening is created in the oocyte 107, other treatment and / or diagnostic devices may be used.

Prior Approach Safe and efficient execution of transseptal perforation during surgery requires considerable technical skill, and currently only a few of physicians perform this type of surgery on a regular and customary basis. In fact, many electrophysiologists are hampered by the practice of transseptal surgery because they are inexperienced and not readily available.

To date, there have been no devices and methods that enable physicians to efficiently perform transthoracic palpation or puncture surgery in an effective manner.

1 is a schematic representation of a cross section of the heart.

2 is a schematic diagram of a location system with a guide shell with a position sensor according to the invention;

3 is a schematic representation of the system of FIG. 2 for use in a patient in accordance with the present invention.

4A is a partial perspective view of the distal end of the first alternative embodiment to the envelope of FIG. 2 in accordance with the present invention.

4b is a partial view of a cross section of the sheath of FIG. 4a in accordance with the present invention;

5 is a partial perspective view showing the distal end of an optional second embodiment of the envelope of FIG.

FIG. 6A is a partial perspective view of the distal end of the skin of FIG. 2 in accordance with the present invention; FIG.

6B is a fragmentary view showing a cross section of the sheath of FIG. 6A in accordance with the present invention.

7 is a partial perspective view showing the distal end of an optional third embodiment of the envelope of FIG. 2 in accordance with the present invention.

8 is a partial perspective view showing the distal end of an optional fourth embodiment of the envelope of FIG. 2 in accordance with the present invention.

9 is a partial perspective view showing the distal end of an optional fifth embodiment of the envelope of FIG. 2 in accordance with the present invention.

10 is a partial perspective view showing the distal end of an optional sixth embodiment of the skin of FIG. 2 in accordance with the present invention.

Figure 11a is a schematic diagram of a guide sheath with a position sensor according to the invention used to identify an ophthalmic vortex in a method according to the invention.

FIG. 11B is a schematic illustration of a guide sheath having a position sensor and a penetrating device according to the invention used to penetrate an oval crypt in the method of FIG. 11A in accordance with the present invention. FIG.

12A is a schematic representation of an intraocular sheath having at least one electrode according to the invention used to identify an ovary in another embodiment of the method according to the invention.

FIG. 12B is a schematic representation of an envelope having at least one electrode and penetrating device according to the present invention used to penetrate an oval crypt in the method of FIG. 12A according to the present invention. FIG.

FIG. 13A is a schematic diagram of a guiding sheath having a position sensor and at least one electrode according to the invention used to identify an ovary in another optional embodiment of the method according to the invention. FIG.

FIG. 13B is a schematic diagram of an envelope having a position sensor and at least one electrode and a penetrating device according to the invention used to penetrate an oval crypt in the method of FIG.

The present invention relates to methods and apparatuses for performing diagnostic and / or therapeutic surgery in tissues and organs. Although the methods and apparatuses according to the present invention can be used in any manner of medical surgery (therapeutic and / or diagnostic surgery), the present invention relates in particular to methods of performing transseptal palpation surgery in the septum wall of the heart. In particular, the methods and apparatuses according to the present invention can be used to accurately identify the location of the ovary, and furthermore the penetration of the septum wall in the ovary by means of a penetrating device (penetration member) for use in particular in the above procedures, including the preceding approach. Can be used to facilitate execution.

One embodiment of the invention is a method of performing surgery on an oval ovary in the septum wall of the heart, which method comprises an outer shell having a body having a lumen penetrating the body and an open end at the distal end of the body. providing a sheath. The body also has at least one electrode at its distal end for sensing the parameters or properties of the tissue (eg the septum wall of the heart). One type of property measured by at least one electrode of the shell body is damage patterns formed on or represented by the tissue. In identifying the ophthalmic fossa in the septum wall, at least one electrode of the envelope is used to identify an oval based on the particular characteristics of the tissue of the septum and, for example, an ophthalmic based on the damage pattern exhibited by both the septum and the oval.

Another aspect of the invention is a device useful for performing surgery on a tissue, such as transseptal palpation surgery. One embodiment of the device according to the invention has a body having a lumen through the body and an open end at the distal end of the body. At least one electrode is disposed at the distal end of the body to determine the damage pattern in the tissue.

Another embodiment of the invention relates to a method of performing surgery on an oval crypt in the septum wall of the heart, the method comprising: a sheath having a body having a lumen penetrating the body and an open end at the distal end of the body; Providing a step. The body also has at least one electrode and a position sensor located at the distal end of the body. The position sensor generates a signal indicating the position of the distal end of the body. The sheath is advanced to the septum wall using a position sensor. The oocytes of the septum wall are then identified using at least one electrode of the shell.

The present invention is also a device for performing surgery on a tissue, for example transseptal palpation surgery, the device having a body having a lumen through the body and an open end at the distal end of the body. The body also includes at least one electrode at the distal end to determine the damage pattern of the tissue. The body also includes a position sensor for generating a signal indicating the position of the distal end of the body.

Another embodiment according to the present invention is directed to a method of performing surgery on an orbital fossa in the septum wall of the heart, the method comprising identifying the septum wall of the heart and identifying the ophthalmic fossa in the septal wall. A point on the oval is identified, and this point is then marked with a tag on the oval. Also used is an outer shell having a body having a lumen through the body and an open end at the distal end of the body. The main body also includes a position sensor at its distal end, which generates a signal indicating the position of the distal end of the main body. The sheath proceeds to the oviary at the marked point using the position sensor. As one example, a tag point is a place coordinate (having location coordinates and direction coordinates) that appears on a map, such as an electroanatomical map. In another embodiment according to the invention, the tag point is a physical tag, such as an active tag or a passive tag, which tag is located at a point located in the ophthalmic fossa of the septum wall (in a confirmed location, ie in position and / or direction coordinates). .

In all embodiments of the method according to the invention, including transseptal palpation surgery, if an oval vortex is identified in the septum wall, a penetrating device (penetration member) is used within the lumen of the envelope body and extends out of the distal end of the envelope body. The distal tip of the penetrates or punctures the orbital cavity, creating a hole in the orbital cavity leading to the left atrium of the heart. Thus, the left atrium of the heart is accessible.

The above objects, features and advantages of the present invention will become apparent from the detailed description set forth below with reference to the accompanying drawings.

The present invention relates, in particular, to methods and apparatuses for performing diagnostic and / or therapeutic surgery, including surgery used to identify particular tissues, such as ovals of the septum wall of the heart, as part of a septal palpation surgery.

The term "tissue" as used herein is used to mean all solid or semisolid cellular materials such as muscles, nerves, connective tissue, vasculature and bone. Blood and other fluid substances, such as lymph, tissue fluid or fluid in the body, are excluded from the definition of "tissue" as defined herein.

One embodiment of the invention encompassed within the diagnostic mapping and treatment delivery system 118 is best shown in FIG. The system is a flexible guide sheath 120 for insertion by the prosthetic 151 into the body 90 in FIG. 3, preferably in the right atrium 115 of the human heart 100 (FIG. 1), for example. The sheath 120 has a distal end 122 and includes a sheath body 120a that forms a lumen passing longitudinally through the body 120a and terminates at the opening 122a of the distal tip 126. The lumen and the opening 122a of the outer shell body 120a serve as a working channel and will be described in detail below.The distal end 122 may describe the electrical properties of the heart tissue, such as the recording of damage patterns. An end tip electrode device 124 (which is a recording electrode device) at the end tip 126 for measurement and recording, and the electrode device 124 is also for diagnostic purposes such as, for example, face mapping, and The heart (10) for therapeutic purposes, for example, to remove defective atrial tissue; It is useful for transmitting electrical signals to 0. Electrode 124 is configured to contact tissue when performing the functions of receiving electrical signals from the heart and transmitting electrical signals to the heart. Note that the electrode device 124 is not always in contact with the tissue, for example, while the electrode device 124 is advanced through the vasculature to the heart 100 or in a heart chamber such as the right atrium 115. It may not come into contact with tissue while going from point to point.

The distal end 122 of the outer shell 120 is optionally provided while the reference electrode 125 is in contact with blood but not in contact with tissue or when both the electrode 124 and the second electrode 125 are in contact with tissue, It may comprise a second electrode 125, such as a reference electrode 125, which provides a reference measurement of internal impedance. The distal end 122 of the sheath 120 also includes a location sensor (also referred to as a position sensor hereinafter) 128 in some embodiments according to the present invention, which sensor is in the patient's body 90. Generate signals used to determine the position and direction coordinates of distal end 122 of sheath 120. Location sensor 128 is preferably adjacent to distal tip 126 of sheath 120. The location sensor 128, the tip 126, and the electrode devices 124 preferably have a fixed position and orientation relationship. Wire 123 carries related signals for electrode 124, electrode 125 (if used), and location sensor 128.

The location sensor (position sensor 128) is used to sense the instantaneous position of the distal end 122 and the distal tip 26 of the shell 120. In a preferred embodiment of the present invention, the location sensor 128 is an AC magnetic field receiver that senses an AC magnetic field generated by a plurality of magnetic field transmitters 127, each of which generates an AC magnetic field to form a fixed frame of reference. It is also referred to as a generating magnetic field generator or radiator. Preferred location sensors 128 are also disclosed in US Pat. No. 5,391,199 and PCT Application PCT / US95 / 01103 (ie WO96 / 05768) (US Patent Application No. 08 / 793,371), which are incorporated herein by reference. I am doing it. The position and orientation coordinates of the distal end 122 and the distal tip 26 of the envelope 120 are determined by determining the position and orientation coordinates of the location sensor 128 (by checking the position and orientation coordinates of the location sensor). In one embodiment of the present invention, location sensor 128 includes one or more antennas 128a (FIGS. 4B and 6B), for example two or three radiators outside the body surface of patient 90 (transmitter: 127). One or more coils or a plurality of coils 128a radiated by. Placement of the transmitter 127 as well as its size and shape will vary depending upon the application of the present invention. Preferably, the transmitter 127 useful in the medical field has wound annular coils having an outer diameter (OD) of about 2 to 20 cm, a thickness of about 0.5 to 2 cm and a coplanar triangular structure, the centers of the coils being about 2 to 30 cm apart. Rod transmitters or equilateral triangle or square coils are also useful in the medical field.

In addition, in a situation in which the lying patient 90 is subjected to an operation comprising the present invention, the transmitter 127 is preferably on or below the surface (such as the operating table 131) on which the patient 90 lies. And is actually placed just below that part where surgery of the patient 90's body is being performed. In other applications, the transmitter 127 may be properly accessible to the skin of the patient 90. The transmitter 127 is preferably driven by the radiator driver in the manner described below, and the signals received by the receiving antenna (coils) 128a of the location sensor 128 are used to drive the transmitter 127. In addition to indicating the signals, they are amplified and processed in the signal processor 140 in the manner described below, and indicate or instruct the position and orientation of the distal end 122 on the monitor or display 142 of the console 134. Done. As long as the transmitter 127 is fixed with respect to a certain reference frame and not overlapping, i.e., unless the two transmitters 127 are placed in exactly the same place, i.e., the same position and direction, the transmitter 127 is in any convenient position and direction. It may be arranged.

When driven by the radiator driver, the transmitter 127 generates a number of distinguishable AC magnetic fields that form a magnetic field sensed by the receive antenna (coil) 128a of the location sensor 128. Magnetic fields can be distinguished in terms of both frequency, phase or frequency and phase of the signals with respect to each magnetic field. In addition, time multiplexing is possible. The location sensor 128 may be composed of a single coil 128a, but preferably includes two or more, more preferably three sensor coils 128a wound around an air core or core material. In a preferred embodiment of the present invention, coil 128a has common axes that are orthogonal, one of which is conveniently aligned with the long longitudinal axis of guide shell 120. Unlike conventional position sensors (used in other applications) that include three coils coaxially located or at least intersecting the axes, the preferred coils 128a of the present invention are closely located along the longitudinal axis of the shell 120. Spaced apart to reduce the diameter of the location sensor 128, thus allowing the sensor 128 to be properly incorporated into the sheath 120 (thus lumen 122a as a channel of action within the guide sheath 120). Forms).

In most aspects of the present invention, a quantitative measurement of the position and direction (by determining position coordinates and direction coordinates) of the distal end 122 and the distal tip 126 of the shell relative to the reference frame is needed. . This fixed frame of reference includes at least two non-overlapping transmitters 127 generating at least two distinguishable AC magnetic fields; A location sensor 128 consisting of at least two non-parallel coils 128a is needed to measure the magnetic field flux resulting from at least two distinguishable magnetic fields. The value of the number of transmitters 127 multiplied by the number of coils 128a is the value of the coil 128a of the location sensor 128 relative to the reference frame established by the fixed transmitter 127 fixed under the table 131. It is equal to or greater than the number of degrees of freedom for the quantitative measurements needed for position and orientation. In a preferred embodiment of the present invention, the six position and direction coordinates (X, Y, Z direction and pitch, yawing direction and rolling direction) for the distal end 122 and the distal tip 126 of the shell 120 are determined. As is desirable, at least two coils 128a are needed for the location sensor 128. It is preferable to use three coils 128a to improve the accuracy and reliability of the position measurement.

In some applications requiring smaller dimensions, the location of the system 118 to determine five position and direction coordinates (X, Y, Z directions and pitch, yaw direction) when used with the transmitter 127 Only one coil 128a may be needed for the sensor 128. Certain shapes and functions of a single coil system (hereinafter also referred to as a 'single axis system') are disclosed in Applicant's US Pat. No. 6,484,118, which is incorporated herein in its entirety. Conductors (wires) 123 are used to convey signals detected by the sensor coil 128a to a signal processor 140 which processes via the base end of the shell 120 to generate the required position and orientation information. . Preferably, the leads 123 are twisted in pairs to reduce pickup and may be further electrically shielded. In one embodiment of the present invention, the coil 128a has 800 turns of internal diameter of 0.5 mm and 16 micrometers, resulting in an overall coil diameter of 1 to 1.2 mm. The effective capture area of the coil 128a is preferably about 400 mm ² . It will be appreciated that the dimensions can vary over a significant range and only show a good range of dimensions. In particular, the size of the coil 128a can be as small as possible 0.3 mm (with some loss of sensitivity) or as large as 2 mm or more. The wire size of the coil 128a can range from 10 to 31 micrometers, depending on the maximum allowable size and wire diameter, and can be between 300 and 2600 turns. The effective capture area should be made as practical as possible to match the overall size conditions. While the shape of the preferred sensor coil 128a is cylindrical, other shapes may be used. For example, a centrally convex barrel-shaped coil may have more turns than a cylindrical coil in a catheter of the same diameter. In addition, square or other polygonal coils may be used depending on the geometry of the shell 120. Location sensor 128 is preferably used to determine whether envelope 120 is in contact with tissue of heart 100 (FIG. 1) and that heart 100 is not moving. During the diastolic phase, the heart 100 is relatively stationary for a short period of time (up to several hundred milliseconds). Instead of using the location sensor 128, the location of the envelope 120 is determined using external sensing or imaging means.

Guide sheath 120 is an over-the-wire sheath that may use a guide wire (not shown) or may be detachably connected to handle 130, such as bending the distal end 122. A control device 132 is included to steer the distal end 122 of the shell 120 in the required direction or to position and / or distal the distal end 122 or distal tip 126 as needed.

As shown in FIGS. 2 and 3, the system 118 further includes a console 134 that allows the user (doctor) 151 to observe and adjust the functions of the sheath 120. Console 134 preferably includes a computer 136, a keyboard 138, and a display 142. The computer 136 allows control and operation of the system 118 and initiates the collection of data from the outer electrode device 24, the second electrode or the reference electrode 125 and data from the location sensor 128. And control circuits for stopping and stopping. The computer 136 also uses electrodes 124 and electrodes 125 (if used) and electrical and / or mechanical and location information obtained from the location sensor 128, which information is conveyed through the wire 123. And processed by the circuits of the signal processor 140 to reconstruct and visualize a map, such as an electrical or electromechanical map of a portion of the heart 100, such as the atrial wall or the atrial septum (IAS) 105.

Signal processor 140 typically receives signals from envelope 120, including signals generated by location sensor 128, tip electrode 124, and second or reference electrode 125 (if used). Have circuits to amplify, amplify, filter, and digitize. The circuits of the signal processor 140 may further include the heart 100 from signals generated at each of the location sensor 128 and the tip electrode 124, as well as the position and orientation (position coordinates and direction coordinates) of the envelope 120. Calculate the electrical properties of the part. In addition, the circuits of the signal processor 140 process ECG signals on the body surface. The signals digitized by the circuits of the signal processor 140 are received at the computer 136 and used to reconstruct and visualize an electrical or electromechanical map for portions of the heart 100 including the septum 105.

In some embodiments of the present invention, return electrode 148 is disposed and used, for example, on an outer surface of patient body 90, and relatively relatively to provide a low impedance between return electrode 148 and patient body 90. Big is good. For example, ElectrosurgicalPatient Plate Model 1149F, supplied by 3M, St. Paul, Minn., Has an area of approximately 130 cm ² , and returns electrode 148 in the systems and methods of the present invention. Can be used satisfactorily.

6A and 6B show the guide sheath 120 used in connection with the location system 118 (FIG. 2). As shown in FIGS. 6A and 6B, the first electrode 124 is a distal tip electrode located at the distal end 122, particularly at the distal tip 126 of the body 120a of the shell 120. In this embodiment of the present invention, the end tip electrode 124 may be of any desired shape, for example a single circumferentially disposed around the end tip 126 of the body 120a as shown. It can be a long segment or a single electrode. The location sensor 128 is disposed at the base of the tip electrode 124 and is disposed in the lumen 122a of the shell body 120a. In this embodiment according to the present invention, the location sensor 128 has a plurality of sensor coils 128a, for example three coils 128a (FIG. 6B). However, as mentioned above, the location sensor 128 may include any number of coils 128a, such as a single coil 128a (as part of a shortened sensor), two coils 128a, three coils, or the like. have. The location sensor 128 is attached to the skin body 120a at a location adjacent the tip electrode 124 in a manner that does not interfere with the lumen 122a of the skin body 120a.

Thus, lumen 122a forms a working channel for conveniently injecting a secondary device, such as through device 150 with a penetrating member, or any other necessary diagnostic and / or therapeutic device, and the diagnosis and / or treatment The device may have a diameter smaller than the diameter defined by lumen 122a to conveniently perform diagnostic and / or therapeutic surgery using intraocular envelope 120, such as novel trans septal palpation surgery according to the present invention described in detail below. It is organized in a way.

An optional embodiment of the guide sheath 120 is shown in FIG. 5 and consists of a single tip electrode 124 circumferentially disposed about the distal end (end tip 126) of the sheath body 120a. In this embodiment, the guide sheath 120 does not have a location sensor. Thus, the envelope 120 of FIG. 5 may be used in conjunction with other imaging and / or location modalities, which modalities may be used such as fluoroscopy devices and ultrasound imaging such as transesophageal echocardiography and intracardiac ultrasound devices. Devices, ultrasound visualization devices, or any other required imaging modalities.

In addition, although the guide sheath 120 shown in FIG. 5 is shown as a single tip electrode 124 disposed circumferentially around the distal end 122 of the body 120a at the distal tip 126, the single electrode 124. ) May be in any desired shape, such as a long segment electrode or the like.

FIG. 7 shows another alternative embodiment for guide shell 120 having distal end 122 with split tip electrode arrangement. In this embodiment according to the invention, the split tip electrode device comprises a semicircular device having two electrode segments 124a disposed at the other half of the distal end 122 at the distal tip 126 of the shell body 120a. do. Insulation 129 separates electrode segments 124a and acts as an insulating barrier located between each electrode segment 124a. The two electrode segments 124a can function as two clearly separated electrodes or the segment 124a can function as a single electrode as needed. Each electrode segment 124a forms a semicircular element at the distal end 126, thereby forming a distal opening of the lumen 122a of the shell body 120a.

8 illustrates another alternative embodiment of the guiding envelope 120 in accordance with the present invention. The shell 120 of FIG. 8 is similar to the semi-circular split tip electrode device shown in FIG. 7, except that it is located within the lumen 122a of the shell body 120a to define the lumen 122a (action channel). The location sensor 128 attached to the inner surface of the () is added, the location sensor 128 is disposed at the base of the semi-circular split tip electrode device (124a). Particular components, features and functions of the location sensor 128 have already been described above. Again, the location sensor 128 is attached to the inner surface of the shell body 120a to form a lumen 122a (action channel) for convenient execution and passage of secondary instruments as described above.

9 shows another alternative embodiment of the guide shell 120 according to the present invention having a semi-circular split tip electrode device having four electrode segments 124b. Each electrode segment 124b is disposed partially circumferentially around the circumference of the distal tip 126 of the distal end 122 of the shell body 120a. Each electrode segment 124b is separated from the adjacent electrode segment 124b by an insulating layer 129, which acts as an insulating barrier between adjacent electrode segments 124b. The semi-circular split tip electrode device ends at an inner end opening in contact with the lumen 122a for convenient use of a secondary device, such as the device described above, for use in the method described below.

In addition, electrode segment 124b may act as four independent electrodes or as four segments of a single electrode (single end tip electrode), as desired.

FIG. 10 shows another optional embodiment of a guide sheath 120 similar to the sheath shown in FIG. 9 with the addition of a location sensor 128, wherein the location sensor 128 includes a lumen ( It is disposed in 122a) and attached to the inner surface of the outer shell body 120a and is located at a location adjacent to the electrode device 124b.

Again, the location sensor 128 is a lumen 122a as a working channel ending in an opening in the distal tip 126 of the body 120a to facilitate the introduction and removal of secondary devices into and out of the envelope body 120a. It is attached to the inner surface of the outer shell body (120a) by forming a.

Optional embodiments of the guide sheath 120 shown in FIGS. 5, 6A, 6B, 7, 8, 9, and 10, respectively, all at least functioning as tip electrodes disposed at the distal tip 126 of the sheath body 120a. Has one electrode. The skin embodiments according to the present invention all have a distal end 122 that ends at the distal tip 126 having a distal opening that contacts the lumen of the sheath body 120a, which lumen prevents the introduction and removal of secondary devices. Acts as a channel of action for. In addition, the optional end tip electrode devices 124, 124a, 124b respectively allow the distal end 122 and the end tip 126 of the guiding sheath 120 to move near or over the tissue of interest. In particular, the tip electrode devices 124, 124a, 124b are each used to sense various characteristics or parameters of tissues and generate signals indicative of the characteristics or parameters of these tissues, which are transmitted via the wire 123 to the system ( It is carried to the signal processor 140 of 118 and measured, analyzed and depicted on the display 142. End tip electrode devices 124, 124a, 124b used in conjunction with intraocular sheath 120 according to the present invention may each be used to detect any type of tissue characteristic or tissue parameter, but the optional end tip electrode devices may be It is particularly useful for detecting and determining damage patterns of. This includes the detection of specific damage patterns in the heart tissue, including the intraarterial septum 105 and ovary 107 of the heart 100 in accordance with new methods of the present invention, which will be described in detail below.

In addition, the guide sheath 120 shown in FIGS. 5, 6A, 6B, 7, 8, 9, and 10 may be used in conjunction with the guide wire in accordance with the present invention, i.e. Act as an "over-the-wire" device. As an alternative, the guide sheath 120 of the invention shown in FIGS. 5, 6A, 6B, 7, 8, 9, and 10 need not be used with a guide wire, and can be used without such a device if necessary, for example. For example, a guide outside may be used with the handle 130 as shown in FIG. 2.

Although intraocular sheath 120 shown in FIGS. 5, 6a, 6b, 7, 8, 9, and 10 can be used for any necessary tissue or organ sensing surgery, intraocular sheath 120 according to the present invention is a transseptal palpation surgery. Especially useful for For example, FIGS. 12A and 12B show the guide sheath 120 of the present invention used in the atrial septum 105 to quickly and effectively identify the orbit 107 as well as the appropriate perforation area within the ovary 107. Doing.

In this process, the guide sheath 120 is placed in the patient's body 90 (FIG. 3) and guided into the lower venous cavity 108 and the right atrium 115. Again, the guide sheath 120 can be used with or without a guide wire (not shown). Guided sheath 120 is guided to intra-atrial septum 105, where the tip electrode device, ie electrode segment 124a, contacts distal tip 126 to septum 105 such that it contacts tissue of septum 105. The distal end of the body 120a is used as a probe. The end tip electrode segment 124a is used as a recording electrode to record the special characteristics of the septum 105, in particular, the damage pattern. The damage pattern detected by the recording electrode segment 124a is passed through the wire 123 to the signal processor 140 (FIGS. 2 and 3) for analysis.

Injury pattern analysis techniques are described in Bidogia et al., "A transseptal left cardiac catheterization: usefulness of intracardiac electrocardiogram, catheterization and cardiovascular diagnosis in localization with ovaries." 24 (3): 221-225 It is explained. When the recording electrode segment 124a is placed in the muscle region of the septum 105 or the free atrial wall, the recording electrode segment 124a shows a significant damage curve and transmits signals indicating the damage pattern. The damage patterns are determined as part of the intraatrial electrocardiogram (EAE), where the EAE is displayed on the display 142 (FIG. 2) for analysis by the physician 151 (FIG. 3). Damage patterns indicated in the ECG format are in the form of a PQRST complex that is analyzed into any necessary combination of segments or waveforms. In addition, when the terminal electrode device (recording electrode segment 124a) enters the endocardium in the septum 105 or in any muscle region of the atrial wall, the induced injury curve or injury pattern is induced by the distal tip (or tip) of the shell 120. 126) gradually increasing pressure on the tissue. In some situations, the greater pressure exerted on the tissue by the distal tip 126 of the distal electrode device results in a strange and complex PQRST complex, i.e. in some cases is represented as a wide and strange monophasic damage curve.

Since the muscular regions of the septum 105 or free atrial wall exhibited a damage pattern as outlined above, the recording electrode segment 124a of the distal tip electrode device held the distal tip 126 against the tissue of the septum 105. It is moved across the septum 105 by moving in the required direction. During movement of the distal tip 126 as the electrode segment 124a to contact the tissue of the septum 105, signals indicative of damage patterns are generated by the distal tip electrode device (electrode segment 124a) and recorded in real time. The signal processor 140 is communicated via a wire 123 to be displayed, and the result of the recording electrode segment 124a is shown on the display 142. Since the ovary 107 has a tissue construct that is a significantly thinner tissue (a thin membrane relative to the muscle area of the septum 105 outside the ovary 107), the ovary 107 is of the same type as the damage pattern exhibited by the muscle region. That is, ovary 107 exhibits a smaller damage pattern than the damage patterns exhibited by the muscular area of the septum 105 (area outside the ovary 107). In addition, in many cases, ovary 107 does not exhibit any damage pattern when recording and registering EAE patterns based on the PQRST complex and special segment analysis.

Thus, the tip tip electrode device, i.e., in this embodiment, exhibits a smaller damage pattern or no damage pattern compared to the damage pattern indicated by the muscle regions of the septum 105 where the recording electrode segment 124a has already been recorded. The recording electrode segment 124a runs along the septum 105 at the distal tip 126 until it generates signals that are not represented. Thus, when achieving this level of damage pattern (a very small or nonexistent damage pattern), it is readily understood that the physician 151 (FIG. 3) has properly identified the oval 107.

As shown in FIG. 12B, when the distal tip 126 of the distal end 122 of the outer shell body 120a is disposed on the oval 107, a secondary device such as a penetrating device 150 having a penetrating member may be used. The penetrating member 150 is introduced into the lumen 122a of the main body 120a and extends through the opening 122a at the distal tip 126 at the distal end of the outer shell main body 120a so that the penetrating member 150 extends to the left atrium of the heart 100. It is used to drill and penetrate oval 107 to make a hole (perforated point in oval 107) that allows access to 110. In the process of penetrating the oval 107 by the penetrating device 150, the penetrating device 150 passes through the lumen 122a of the shell body 120a and out of the distal tip 126 at the distal opening of the body 120a. Is extended. When enough holes are made in the oval 107 to access the left atrium 110, the penetrating device 150 is removed from the lumen 122a of the outer shell body 120a and the other secondary device through the lumen 122a. It can be inserted into the body 120 and extend out of the distal tip 126 of the body 120 into the left atrium 110 of the heart 100 through a hole (perforation point in the ovary 107). Thus, the other secondary device allows the physician 151 to perform diagnostic procedures and / or therapeutic surgery by the secondary device in the left atrium 110.

Based on the signal differences generated by the end tip electrode device, i.e., the recording electrode segment 124a of this embodiment, the physician 151 (FIG. 3) records the recorded endocardial signal generated by the recording electrode segment 124a. The ovary 107 by gradually moving the distal end 122 (at the distal tip 126) of the guiding envelope 120 along the septum 105 (with or without an imaging modality, such as a viewing device) while reviewing them. The distal end 122 of the shell 120 is relatively stable, one electrode segment 124a records the damage pattern, while the other second electrode segment 124a has a similar signal. Or if the pattern (in the form of a damage pattern that is smaller than the damage pattern recorded by the first electrode segment 124a) is not recorded, the doctor 151 indicates that the second electrode segment 124a is in contact with the oval 107; Currently contacting or placed in I can think of. By moving the distal tip 126 more in the direction of the second electrode segment 124a, ie by slightly adjusting the distal end 122 position, both recording electrode segments 124a are described above. The transseptal puncture and palpation surgery as will be placed within the oval 107 so that it can be stably performed.

In addition, the doctor 151 can easily check whether the distal end 122 of the outer shell 120 has entered the left atrium 110, ie, after passing through the newly created hole in the oval 107 of the septum 105. It can be easily confirmed that the outer shell 120 in the left atrium 110. This confirmation is indicated by the distal end 122 of the sheath 120 passing through the septum 105 through a hole made in the oval 107 and the heart 100 living in the left atrium 110 after the recording electrode segment 124a. This is possible when a sudden change in the recorded P-wave or P-segment appears.

13a and 13b show an alternative embodiment of the method according to the invention. The method of the present invention shown in FIGS. 13A and 13B also relates to surgery involving septum 105 and oval 107, such as transseptal palpation surgery. Said optional embodiment of the method according to the invention is similar to the transseptal palpation method shown in Figs. 12A and 12B, as described above, i.e. both the method embodiments of 12A and 12B and the method embodiments of Figs. 13A and 13B Substantially similar except for using the location sensor 128 within the sheath body 120a for the sheath 120 associated with the method embodiment of FIGS. 13A and 13B.

Thus, the method of the present invention, shown in FIGS. 13A and 13B, not only guides (eg, electromagnetic field guidance or steering) the distal end 122 of the sheath 120 to the septum 105 of the heart 100 (FIG. 1) but also distals. End tip electrode device, ie, recording electrode segment 124a, for guiding movement across the tip 126 and end tip electrode device, i.e., the recording electrode segment 124a, against the tissue of septum 105 and oval 107. It is a navigated transseptal palpation surgery using a location sensor 128 disposed adjacent to the location sensor 128. The location sensor 128 stores the location coordinates of the distal end 122 of the shell 120, ie, the location coordinates and the direction coordinates. As it generates signals to determine, envelope 120 uses only location system 118 (FIGS. 2 and 3), ie, to guide cardiac 100 and into cardiac 100 without the aforementioned imaging modalities. And can be steered, therefore, shown in Figures 13A and 13B. The steered septal palpation method does not necessarily require an imaging modality such as a fluoroscopy or any other examination described above, so that the physician 151 (FIG. 3) is provided from a location sensor 128 instead of the imaging modalities. You can rely on place information. However, envelope 120 with location sensor 128, as shown in FIGS. 13A and 13B, may be removed from the subject by the physician 151 if desired, even if there is no requirement according to an embodiment of the method of the present invention. Can be used with the required video format.

When using the location sensor 128 at the distal end 122 of the sheath 120, the end 122 of the sheath 120 proceeds to the septum wall 105 using the location sensor 128. In addition, as described in detail above (with respect to the method embodiment shown in FIGS. 12A and 12B), the ovals 107 may be formed using the recording electrode segment 124a and damage pattern detection techniques described above in detail, using the septum wall ( 105).

Moreover, as described above, the oval 107 is defined by other regions on the septum wall 105, ie by muscle regions of the septum wall 105 such as those regions that are outside of the oval 107. It is identified as the area on the septum wall 105 with less or no damage pattern compared to the damage pattern shown.

The only difference between the method embodiments of FIGS. 13A and 13B when compared to the method embodiments shown in FIGS. 12A and 12B is that the location sensor 128 is attached to the envelope 120 and the ability to proceed using imaging modalities such as fluoroscopy. This capability has been replaced by the electromagnetic steering capabilities allowed by location sensor 128 and location system 118 (FIG. 2).

12A, 12B, 13A, and 13B, the embodiments of the transseptal palpation method, respectively, are illustrated in FIG. 5, 6A, 6B, 7, 8, 9, and 10. It can be performed with any of the embodiments. Thus, the tissue characteristic or damage pattern recording technique described in the method embodiments does not limit the end tip electrode device having two recording electrode segments 124a, and also as shown in Figs. 5, 6A and 6B. A semi-circular end tip recording electrode device shown in FIGS. 9 and 10 as well as an end tip recording electrode device using a single end tip electrode 124 such as a columnar arrayed end tip recording electrode 124 (four recording electrode segments ( 124b)).

Although the envelope embodiment of FIG. 6A of the present invention is schematically illustrated in the method embodiment of FIGS. 12A and 12B, while the envelope embodiment of FIG. 8 is schematically illustrated in the method embodiment of FIGS. 13A and 13B, it is seen as a transseptal palpation surgery. The above optional embodiment of the method according to the invention does not limit such a special skin embodiment (ie semicircular split tip recording electrode device).

Another optional embodiment of envelope 120 according to the present invention is shown in FIGS. 4A and 4B, respectively. In this skin embodiment according to the present invention, the skin 120 has a distal end 122 without any type of recording electrode device. Rather, only the location sensor 128 is disposed at the distal end 122. As noted above, the location sensor 128 advances the sheath 120 into the patient's body 90 and directs it to any desired location within the body 90, such as a particular tissue site. Since the particular shape, shape and function of the location sensor 128 and the location system 118 (FIG. 2) have been described in detail above, a new method of using the skin embodiment of FIGS. 4A and 4B will now be described.

Thus, one method of using the envelope 120 embodiment shown in FIGS. 4A and 4B relates to identifying a tissue site, such as the oval 107 of the septum wall 105, and is associated with transseptal palpation surgery. . 11A and 11B illustrate the skin 120 embodiment of FIGS. 4A and 4B, where an optimal perforation 145 (also referred to as a 'tag') is achieved through various available methods. This involves identifying the septum wall of the heart, including the muscle regions on the septum wall 105 of the heart 100, as well as the fibrous regions where the ovary 107 is thin. Such tissue identification methods are modalities such as appendages of the right atrium 115, anatomical landmarks for the right atrium, and the area of the His bundle that can be used as geography and a projection device that can be used as an electrode catheter disposed within the cardiac vein. , Angiography, or the use of ultrasound visualizations such as transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE). When the oval 107 is identified in the septum wall 105, a tag (tagged perforation 145) is applied to the point of the oval 107. The tagged puncture site 145 may be a special place coordinate (identified by position and orientation coordinates) determined using the location sensor 128, or the tagged puncture site 145 may be applied to the tissue of this site. It can be a physical tag, such as a placed active tag or a passive tag. Examples of active tags and passive tags that can be used as the tagged punched portion 145 (tag point) are described in US Pat. No. 6,332,089; US patent application Ser. No. 09 / 265,715, filed March 11, 1999; US Patent Application No. 10 / 029,595, filed December 21, 2001; And US patent application Ser. No. 10 / 173,197, filed June 17, 2002, the disclosure of which patents and applications are incorporated herein by reference.

The tagged puncture site 145 or tag point in the oocyte 107 may be a variety of ultrasound imaging devices, including projection imaging devices, angiography imaging devices, esophageal echocardiography or intracardiac echocardiography. Can be confirmed using imaging modalities or imaging devices. Additionally, the tagged puncture site 145 or tag point can be identified using anatomical landmarks as described above.

In addition, the tagged puncture site 145 or tag point in the oocyte 107 may be subjected to electroanatomical mapping using in conjunction with the location system 118 (FIG. 2) and the surface reconstruction software of the system detailed above. Can be confirmed. When using the location system 118 in electrohaematological mapping surgery, the tag points are displayed on an electroanatomical map in the display of the system 118 as shown in FIG.

After verifying the tag point 145 using the special place coordinates determined using the location system 118 or using a physical tag (active or passive tag as described above), the envelope 120 is located in the location sensor 128. Is guided to the tag point 145 of the oval 107 and proceeds.

As best shown in FIG. 11B, the penetrating device 150 is inserted into the lumen 122a of the body 120a of the shell 120 and extends out of the opening in the distal end 122 of the body 120a. The member 150 drills through the tagging point 145 (tagged perforation 145) in the oval 107 and thus makes a hole in the oval 107 that leads to the chamber of the left atrium 110. Again, the above description Additional steps related to transseptal palpation surgery, such as one step, remove the penetrating device 150 from the lumen 122a of the sheath 120 and fit within the lumen 122a (action channel) of the sheath 120. And providing other types of secondary devices (diagnostic or therapeutic devices) in the shape, thus allowing the secondary devices to successfully penetrate the tagging point 145 of the ovary 107. May be used to perform diagnostic surgery and / or therapeutic surgery in the left atrium 110. have.

Embodiments of all guide sheaths 120 respectively shown in FIGS. 4A-10 may be used with or without guidewires (not shown) using the various guidance and steering techniques described above.

The foregoing preferred embodiments are mentioned by way of example and the full scope of the invention is limited only by the claims.

The methods and apparatuses according to the present invention can be used to accurately identify the location of the ovary, and also facilitate the penetration of the septum wall in the ovary by a penetrating device (penetration member) for use in particular in the above procedures, including the preceding approach. Can be used to run

Claims (20)

In the method of performing surgery on the oval ovary in the septum wall of the heart, Providing an outer shell having a lumen extending through the body and an open end of the distal end of the body and having a body having at least one electrode at the distal end of the body; Using the at least one electrode of the envelope to identify an ovary in the septum wall. 10. The method of claim 1, further comprising the step of identifying ophthalmic fossa based on damage patterns detected using at least one electrode. 3. The method of claim 2 further comprising the step of identifying the ophthalmic fossa by determining a damage pattern for the area of the septum wall that exhibits less than the damage patterns seen in certain areas of the septum wall. The method of claim 2, further comprising identifying the ophthalmic fossa by finding areas of the septum wall that do not exhibit a pattern of damage. 4. The method of claim 3 further comprising detecting damage patterns using damage curves. The method of claim 5, further comprising detecting damage patterns by electrocardiogram. The method of claim 6, further comprising displaying damage patterns in the form of a PQRST waveform. The method of claim 2 further comprising penetrating the oval crypt. 10. The method of claim 8, further comprising penetrating the oviary by extending the penetrating device through the lumen and the distal end of the sheath and generating a penetrating point. The method of claim 9, further comprising removing the penetrating device from the sheath. The method of claim 10, further comprising extending the secondary device through the sheath and the point of penetration into the left atrium of the heart. The method of claim 11, further comprising performing diagnostic surgery in the left atrium by the secondary device. The method of claim 11, further comprising performing a therapeutic surgery in the left atrium by the secondary device. In the apparatus for performing surgery on tissue, And a main body having a lumen extending through the main body, an open end at the distal end of the main body, and at least one electrode at the distal end for determining a damage pattern in the tissue. 15. The surgical execution device of claim 14, wherein the at least one electrode comprises a tip electrode. The apparatus of claim 15, wherein the tip electrode is a circumferential tip electrode. The apparatus of claim 14, wherein the at least one electrode comprises a plurality of electrode segments. The device of claim 17, wherein the plurality of electrode segments consists of two electrode segments. The apparatus of claim 17, wherein the plurality of electrode segments consists of four electrode segments. The apparatus of claim 14, wherein the at least one electrode comprises a first electrode and a second electrode.